AccessGUDID - DEVICE: Ambu Pedicle Screw ProbeSingle Patient Probes (05707480108497)

GUDID

Device Identifier (DI) Information

Brand Name: Ambu Pedicle Screw ProbeSingle Patient Probes
Version or Model: 73600-190/10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73600-190/10
Company Name: Ambu A/S

Primary DI Number: 05707480108497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu Disposable IOM Stimulation Probes 100 mm long Pedicle Screw needle with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	ELECTRODE, NEEDLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Millimeter
Length: 190 Centimeter

Device Record Status

Public Device Record Key: e8fc302a-fe9f-4842-9acb-70dc9c9e32d8
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016